SNGX: Agreement with EMA on Second Confirmatory Trial for HyBryte™… [Yahoo! Finance]
Soligenix, Inc. (SNGX)
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Source: Yahoo! Finance
Reaches Agreement with European Medicines Agency on Second Confirmatory Trial for HyBryte™ On April 3, 2024, Soligenix, Inc. (NASDAQ:SNGX) announced it has reached agreement with the European Medicines Agency (EMA) on the key design elements for a confirmatory Phase 3 trial of HyBryte (synthetic hypericin) for the treatment of cutaneous T cell lymphoma (CTCL). The proposed Phase 3 FLASH 2 trial will be a randomized, double blind, placebo controlled, multicenter study that will enroll approximately 80 subjects with CTCL. HyBryte will be applied topically to CTCL lesions twice weekly for 18 weeks, with each application followed 21 (± 3) hours later by the administration of visible light at a wavelength of 500 to 650 nm. The light will be administered starting at 6 J/cm and will be increased upwards by 2 J/cm until: 1) the patient experiences a Grade 1 erythema; 2) the patient reaches a maximum dose of 30 J/cm , or 3) the patient cannot tolerate the treatment time, whichever comes f
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SNGX
Sec Filings
- 4/29/24 - Form ARS
- 4/29/24 - Form DEF
- 4/22/24 - Form 8-K
- SNGX's page on the SEC website